Cleared Traditional

K160710 - Oasis Lacrimal Intubation Set

K160710 · Anodyne · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 2016
Decision
59d
Days
-
Risk

K160710 is an FDA 510(k) clearance for the Oasis Lacrimal Intubation Set. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Anodyne (O' Fallon, US). The FDA issued a Cleared decision on May 13, 2016 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Anodyne devices

FDA 510(k) Submission Details - K160710

510(k) Number K160710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 15, 2016
Decision Date May 13, 2016
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

OKS Device Classification - Class 0,

Product Code OKS Lacrimal Stents And Intubation Sets
Device Class -
Definition Lacrimal Stents And Intubations Sets Are Intended To Repair The Lacrimal Drainage System. Lacrimal Stents And Intubations Sets Are Indicated For, But Limited To, The Treatment Of Epiphora In Infants And Adults; Canalicular Pathologies Such As Stenosis; Obstruction Or Laceration; And Conditions Requiring Dacryocystorhinostomy (conventional Or Laser); Or Imperforation Of The Nasolacrimal Duct In An Infant.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

All 24
Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K160710.
LacriJet®
K201606 · Fci (France Chirurgie Instrumentation) Sas · Dec 2020
Lacriflow CL
K170247 · Kaneka Pharma America, LLC · Apr 2017
Nunchaku
K161373 · Fci (France Chirurgie Instrumentation) · Nov 2016
DacryoCATH
K142914 · Armadillo Biomedical, LLC · Jan 2015
STOPLOSS JONES TUBE
K140290 · Ljt Surgical, Ltd. · Dec 2014
SELF-RETAINING BICANALICULUS INTUBATON SET II
K130375 · Fci Sas (France Chirurgie Instrumentation) · Dec 2013